PDS Biotechnology Corporation
1.0100+0.08 (+8.25%)
Oct 29, 4:00:00 PM EDT · NasdaqCM · PDSB · USD
Key Stats
Market Cap
47.50MP/E (TTM)
-Basic EPS (TTM)
-0.91Dividend Yield
0%Recent Filings
8-K
8-K
Extended survival in low PD-L1 cohort
PDS Biotechnology unveiled a sub-analysis from its VERSATILE-002 Phase 2 trial, revealing 29.5 months median overall survival in the low PD-L1 expression cohort (CPS 1-19, n=32) treated with PDS0101 plus Keytruda, dwarfing the 10.8 months from Keytruda alone and 12.3 months with added chemotherapy. This breakthrough targets a tough subset comprising 60% of trial patients, hinting at chemotherapy-free options for advanced HPV16-positive head and neck cancer. Full data publication looms later this year. Yet risks like trial funding and regulatory hurdles persist.
8-K
Strong survival data released
PDS Biotechnology announced final topline data from its VERSATILE-002 Phase 2 trial on August 25, 2025, showing a median overall survival of 39.3 months for HPV16-positive first-line recurrent/metastatic head and neck squamous cell cancer patients treated with PDS0101 plus pembrolizumab, far exceeding the 17.9 months from standard pembrolizumab or chemo combos. The combo induced durable HPV16-specific CD8+ T cells across demographics, with no discontinuations due to adverse events. VERSATILE-003 Phase 3 is underway. PDS0101 advances simply.
8-K
PDSB unveils strong PDS0101 survival data
PDS Biotechnology updated its corporate presentation on August 25, 2025, spotlighting Phase 2 VERSATILE-002 results for PDS0101 plus pembrolizumab in HPV16+ first-line recurrent/metastatic head and neck squamous cell carcinoma, showing a median overall survival of 39.3 months versus the standard 12-18 months benchmark. The therapy achieved a 35.8% objective response rate and 77.4% disease control rate, well-tolerated with only 9% Grade 3 adverse events. Phase 3 VERSATILE-003 is now recruiting 351 patients to confirm these survival gains. PDS0101 stands alone with reported positive data in this space.
10-Q
Q2 FY2025 results
PDS Biotechnology narrowed its Q2 operating loss to $7.6 million, down 12% year-over-year from $8.7 million, as research and development expenses fell 7% to $4.2 million amid lower manufacturing and personnel costs, while general and administrative outlays dropped 18% to $3.4 million. For the first half, the operating loss improved 11% to $16.7 million versus $18.8 million last year, driven by similar efficiencies despite rising clinical trial spending. Net loss widened slightly to $9.4 million in Q2 and $17.9 million YTD, reflecting higher interest expense of $2.1 million quarterly from new convertible debentures closed April 30, 2025, for $20 million (principal $22.2 million at prime +5%, maturing April 30, 2028), which retired prior debt but added $18.5 million total liabilities. Cash dipped to $31.9 million from $41.7 million year-end, with operating cash use at $18.1 million YTD; free cash flow not disclosed in the 10-Q. Diluted EPS of $(0.21) Q2 and $(0.41) YTD aligns with 45.9 million and 43.2 million weighted shares, respectively, amid anti-dilutive options and warrants. Momentum builds from VERSATILE-003 Phase 3 initiation in March 2025. Yet regulatory approvals remain uncertain.
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